Efficacy and Safety of Convalescent Plasma in Treating COVID-19 Hospitalized Patients

Completed · Phase 2

Conditions studied: COVID-19

In brief

This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.

Key facts

Study ID

NCT04354831

Run by

Medical College of Wisconsin

People needed

131

Starts

2020-05-11

Expected to finish

2021-02-10

Last updated by the study team

2024-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years or older
• Hospitalized as an in-patient with positive COVID-19 test by PCR
• Presence of respiratory symptoms with any of severe features as below:
• Respiratory Rate ≥ 24/min
• Oxygen Support >3L/min by nasal cannula
• New onset or worsening of respiratory symptoms with radiologic confirmation of bilateral ground glass opacities that cannot be attributed to another cause
• Patient / HCPOA must agree to storage of blood specimens for future testing.
• Patient / HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, health care POA should be defined and able to consent for the patient.
• Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted.

You may not qualify if…

• FCBP with positive pregnancy test (mandatory)
• Breastfeeding females
• Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies .
• Mechanical ventilation for > 14 days
• Days from symptom onset >21 days
• Expected survival < 72 hours
• Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI
• Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort. These patients could need ICU level care subsequently and at that time point could be considered for ICU cohort .

Where it is running

• Froedtert Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.